Effect of Hypopressive Gymnastics Associated or Not With Pelvic Floor Muscle Training in Women With Urinary Incontinence

NCT ID: NCT04339010

Last Updated: 2020-04-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-02
• Study Completion Date: 2020-03-30

Brief Summary

Aim: To verify the effects of the abdominal hypopressive technic (AHT) associate or not with pelvic floor muscle training (PFMT) in urinary incontinence (UI) symptoms and pelvic floor muscle strength. Methods: Randomized controlled trial. Thirteen incontinent women were randomly divided into an AHT group or AHT+PFMC group. Outcome assessment was carried out using digital palpation (modified Oxford grading scale), Peritron perineometer, and the International Consultation Incontinence Questionnaire-Short Form (ICIQ-SF) questionnaire. The treatment protocol consisted of five twice-weekly, 40-min one-on-one sessions. The participants were assessed only at baseline and after the intervention. Results: It is expected that the group who performed PFMC will improve the maximal voluntary contractions (MVC) and improve urinary incontinence symptoms, while the hypopressive exercise does not.

Detailed Description

This was a single-blind randomized controlled trial comparing the effect of AHT versus AHT associated with PFM contraction in incontinent women. The study was approved by the Research Ethics of Santa Catarina State University (number 3.712.850) and each participating provided the written informed consent signed. Women were randomly assigned to either an AHT group or the AHT associated with PFM contraction (AHT + PFMC) group. The first group underwent a hypopressive exercise program that does not stimulate the PFM contraction, while the other group receives the AHT associated with PFM contraction stimulated by the physiotherapist during the sessions. Following eligibility screening by the research, the women were allocated in an of the two groups. Group allocation results were concealed by opaque, sealed envelopes with serial numbers, and the participants were assigned at the second visit by opening envelops in a sequential manner, after their eligibility was assessed at the first visit. Study investigators were blinded to treatment allocation. Participants underwent a five weeks intervention after the first evaluation, and the final evaluation occurred one week later on a date according to the participant availability.

The first three sessions were designated to learn how to perform the exercises and your variations correctly were part of the five weeks intervention. The intervention was performed in a forty-minute training session in two-week meetings during five consecutive weeks. All women included in this trial, independently of the group, received standardized lifestyle advice including, when appropriate, instructions about weight loss, constipation, hydration and the avoidance of heavy lifting. It is very important to emphasize that the time dedicated to performing the daily exercises was similar. The therapist applying the protocol was appropriately trained especially for the trial and it was not the same professional who conducted the evaluations.

Conditions

Urinary Incontinence; Quality of Life; Pelvic Floor Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Hypopressive

1. st session: the meetings were provided by a physiotherapist, who also discussed the location and function of the pelvic organs, PFM, and the transversus abdominis (TrA) muscles. The participants learned how to activate TrA muscles. The training was performed during full expiration, the physiotherapist check and coordinate the group to maintain the Tra contraction. The women were also trained to inhale through the nose and exhale through the mouth maintaining an apical breathing pattern.

2. nd session: The contractions were executed during six different positions the ones which they will keep following through the whole treatment.

3. rd session: The patients were exposed to all the six positions (supplementary material) and their three variations (positions 1, 3, 5 and 6 ). Every meeting obeyed the same schedule through the five weeks of treatment and was accompanied by two physiotherapists.

Group Type: EXPERIMENTAL

Hypopressive exercise

Intervention Type: OTHER

The hypopressive exercise is performed mainly via transversus abdominis (Tra) activation. The exercise relaxes the diaphragm, decreases intra-abdominal pressure and may activate the abdominal and PFM simultaneously.

Hypopressive + PFMC

This group receives the same protocol than the Hypopressive group, but with a verbal command to realize the PFM contraction during the activation of the deep abdominal muscle.

Group Type: ACTIVE_COMPARATOR

Hypopressive exercise

Intervention Type: OTHER

The hypopressive exercise is performed mainly via transversus abdominis (Tra) activation. The exercise relaxes the diaphragm, decreases intra-abdominal pressure and may activate the abdominal and PFM simultaneously.

Pelvic floor muscle contraction

Intervention Type: OTHER

Pelvic floor muscle contraction (PFMC) is performed through a sequence of contraction and relax the PFM. It will improve PFM strength and is effective for treating urinary incontinence.

Interventions

Hypopressive exercise

The hypopressive exercise is performed mainly via transversus abdominis (Tra) activation. The exercise relaxes the diaphragm, decreases intra-abdominal pressure and may activate the abdominal and PFM simultaneously.

Intervention Type: OTHER

Pelvic floor muscle contraction

Pelvic floor muscle contraction (PFMC) is performed through a sequence of contraction and relax the PFM. It will improve PFM strength and is effective for treating urinary incontinence.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

-

Exclusion Criteria

-

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of the State of Santa Catarina

OTHER

Sponsor Role: lead

Responsible Party

Gilmar Moraes Santos, PT

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Center for Health and Sport Sciences

Florianópolis, Santa Catarina, Brazil

Countries

Brazil

Other Identifiers

Hypopressive gymnastics

Identifier Type: -

Identifier Source: org_study_id